In Vitro
Diagnostics (IVD)

services-star

Diagnostic technologies move healthcare forward by enabling faster and more informed clinical decisions. Bringing them to market, however, requires balancing scientific evidence, regulatory compliance, and performance validation. GSAP helps IVD companies navigate this complexity with integrated expertise spanning regulatory, quality, clinical, validation, and market access planning.

Lab device

How We Support IVD Companies

 

  • Regulatory Strategy & IVDR Pathways
    Development of regulatory strategies, product classification, regulatory planning, and submission pathways for IVD products in global markets, including support for IVDR compliance and market authorization activities
  • Performance Evaluation & Clinical Evidence
    Support for performance evaluation strategies, performance evaluation plans and reports (PEP & PER), clinical evidence generation, and documentation supporting regulatory submissions and market access
  • Quality Systems & Compliance
    Establishment, implementation, remediation, and ongoing management of Quality Management Systems (QMS) aligned with ISO 13485, IVDR, FDA QMSR, and other applicable regulatory requirements
  • Analytical Validation & Performance Verification
    Support for analytical performance verification, validation planning, test method validation, design controls, verification and validation activities, and performance assessment programs supporting IVD development
  • Regulatory Submissions & Technical Documentation
    Preparation and review of technical documentation, performance evaluation documentation, regulatory submissions, and interactions with notified bodies, competent authorities, and other regulatory agencies
  • Engineering, Validation & Laboratory Integration
    Support for manufacturing readiness, design transfer, process validation, equipment qualification, computerized systems validation (CSV), laboratory operations, and validation activities supporting IVD products and testing environments
  • Post-Market Compliance & Lifecycle Support
    Support for post-market activities, regulatory updates, incident investigations, vigilance activities, documentation maintenance, and ongoing compliance throughout the product lifecycle